IRBs have accumulated a lot of responsibilities and processes over the years, and some of it is not necessary or not really part of the IRB’s role, experts say.
By overhauling IRB processes and using electronic data in a focused quality improvement initiative, an IRB can make its operations more efficient and faster, according to Candice Yekel, MS, associate vice president for research in the Office for Research Protections at Pennsylvania State University in University Park.
“Our IRB was going well beyond what was required in the regulations — mission creep,” Yekel says.
“We wanted to peel back and say, ‘What is the IRB supposed to do?’” she adds. “And we want to do those things very well, so it might be a good idea to rethink how we are doing things.”
This type of project is bigger than the IRB, notes Sara Horn, CIP, assistant director in the Office for Research Protections at Penn State.
For Penn State, the project spans all other compliance committees, as well as the IRB. These include the institutional biosafety, animal care and use committees, and others.
Yekel and Horn offer these suggested steps for overhauling processes and compliance mission:
1. Evaluate staff structure and workflow.
The Penn State HRPP enlisted help from consultants and began the process of evaluating its staff structure and its efficiency.
“We realized our staff structure and way we processed submissions related to staff structure wasn’t the most efficient system,” Horn says. “Researchers were experiencing inconsistency from one review to the next, and we wanted to put a process in place that ensured some consistency.”
As the IRB reviewed its staff structure, they realized that some roles could be restructured, Horn adds.
“We didn’t have a true director of our IRB program at the time and we had gone through a lot of changes, so we first acknowledged that the IRB needed its own leadership,” Horn explains.
Previous to the transition, there was a director who was responsible for many compliance areas. The change would mean the IRB would have its own director, Yekel says. “It’s better to have someone in that position who knows what’s going on and is managing the program right there in the trenches.”
In Horn’s role as assistant director of the Office for Research Protections, she manages the day-to-day IRB program activities and serves as a member on both IRBs at the University Park location.
“Through the re-evaluation of our staff and their qualifications, we were able to restructure our staff into two different teams,” Horn explains.
Each team consists of a senior IRB program leader and IRB analysts.
“Previously, we had what we called team leaders, but they didn’t have a vested interest in leadership or the overall direction of the program,” Horn says. “This formalized that position and created more of a career ladder within the program.”
Team leaders were the IRB employees who had the most seniority and the greatest depth of knowledge, Yekel says.
In their new roles, they have a vested interest in making sure the program is running smoothly and they are responsible for the outcomes and performance of IRB reviews, she adds.
Another staff change was to shift the IT responsibility from the IRB analysts, who had been handling much of the IRB software issues, and — instead — use IT staff to maintain the electronic system, Yekel says.
“We also have business analysts to do a lot of the heavy lifting, such as gathering information about the needs of the IRB and developing solutions for the electronic system that meet those needs,” she adds. “Now, IRB analysts are no longer involved in building or maintaining an electronic system and they are focused on IRB-related work.”
2. Budget for maintenance and repairs.
One of the failures of the HRPP’s previous electronic system was that the program didn’t have dedicated staff to handle electronic management of the system, Yekel says. “We had some IT people, but staffing was limited; now we have an IT workforce to maintain and customize the system.”
This change was a big shift, she adds.
3. Drill processes down to what’s necessary and in the regulations.
“We have worksheets that help the staff look for things required by the regulations in the informed consent forms,” Horn says. “One of our big changes involves the mentality surrounding the review; our analyst in the past might have had a long list of specific statements to add to the informed consent form.”
But the regulations do not require the insertion of specific language in the consent form, Horn adds.
“So now we go back to investigators and say, ‘What are you doing, and how would you like to have this put in the informed consent?” Horn says. “We’ve gotten rid of old required phrases and let investigators use their own words.”
4. Create a more efficient IRB meeting.
“We’ve made some changes to our IRB meetings,” Horn says. “One effort was getting IRB members to focus on the criteria for review when reviewing a study.”
Previously, the IRB office provided support materials for IRB members, and they’d gather to talk about regulations, she notes.
As part of the change, Horn would display HRPP regulations on a large screen for IRB members to view while they discuss a protocol. “We discuss each regulation, one by one, to see if the entire board feels that a particular regulation was met or was not met,” she says. “We literally have a very clear and transparent discussion about whether something is meeting criteria outlined in the regulations.”
While Horn doesn’t display the regulations at every meeting now, she still brings the criteria for review up on the screen and asks IRB members to make certain the criteria are met.
“IRBs can get hung up on the minutia and forget that a protocol needs to meet the criteria for approval, and making that determination should be the most important thing they do,” Yekel notes.
“Anytime the IRB requests a modification required for approval, we have them indicate the review criteria that is not being met and the exact change that needs to be made,” Horn says. “Then we communicate with the investigator, saying, ‘We want you to make this change and here’s why.’”
This transparency alone has produced a dramatic change, Horn notes.
“I’ve seen a dramatic change in the content of the discussions of the IRB, and they are certainly more focused on real risks to participants and more focused on those regulatory criteria for approval,” Horn adds.
Another change was to have an IRB analyst take minutes during the IRB meeting instead of recording the meeting, and then having a staff assistant transcribe minutes later, Horn adds.
“IRB analysts have a lot of knowledge about the protocol, so it makes sense to have them take minutes,” she explains. “They attend meetings for the protocols they coordinate; they’re taking minutes and helping with the meeting should the IRB need it.”
The IRB meetings also achieved greater efficiency by switching from a hybrid electronic-paper process to a fully electronic review process, she adds.
IRBs have accumulated a lot of responsibilities and processes over the years, and some of it is not necessary or not really part of the IRB’s role, experts say.
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